Navigation Links
BioDelivery Sciences Provides Update on Status of Modified REMS Program for ONSOLIS
Date:6/2/2011

RALEIGH, N.C., June 2, 2011 /PRNewswire/ -- BioDelivery Sciences International, Inc. (BDSI®) (Nasdaq: BDSI) provided an update on progress with the modified REMS (Risk Evaluation and Mitigation Strategy) program for ONSOLIS (fentanyl buccal soluble film), which among other changes, is expected to allow for dispensing of ONSOLIS from retail pharmacies.  

(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO)

BDSI's commercial partner Meda Pharmaceuticals submitted the modified REMS to the U.S. Food and Drug Administration (FDA) in early December 2010.  Amendments to REMS programs typically fall under a six month FDA review timeframe, but the FDA has no obligation to meet such timeline.

"Meda and BDSI continue a close dialogue and final document exchange with the FDA in order to gain approval of a modified REMS program that seeks to reduce some of the unintended barriers to prescribing and expand access to ONSOLIS for appropriate patients by making it available in retail pharmacies," said Dr. David Wright, Vice President, Regulatory Affairs for BDSI.  "This amendment was a document intensive undertaking involving the creation of numerous documents which are under final review by various levels and disciplines within the FDA.  While we anticipated this review would be completed by this time, we are working diligently with our partner Meda and the FDA on the few remaining components that we believe will allow for the final approval of the modified REMS program sometime this summer.  Given this final approval is dependent largely on the FDA's constraints, we cannot be any more precise regarding the exact timing for ultimate approval."  

About BioDelivery Sciences International

BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics.  BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care.  BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer.  The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).  BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation for the treatment of opioid dependence.  Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron).  BDSI's headquarters is located in Raleigh, North Carolina.  For more information, visit www.bdsi.com.

BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc.  ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc.  BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.

Cautionary Note on Forward-Looking Statements

This press release, the presentation described herein and the statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission.  Actual results (including, without limitation, timing for completion and results of the FDA's review of the modified REMS program described herein) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control).  The Company undertakes no obligation to publically update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.  Readers are cautioned that peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such estimates are accurate or that such sales levels will be achieved, if at all.


'/>"/>
SOURCE BioDelivery Sciences International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. MonoSol Rx, LLC Files Patent Infringement and False Marking Lawsuit Against BioDelivery Sciences International, Inc., MEDA Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc.
2. BioDelivery Sciences Announces BEMA Buprenorphine Phase 3 Chronic Pain Study More Than 50% Recruited and on Schedule
3. BioDelivery Sciences Confirms 505(b)(2) Pathway for BEMA Buprenorphine/Naloxone for Opioid Dependence Following FDA Meeting
4. BioDelivery Sciences to Present at the 23rd Annual ROTH OC Growth Stock Conference
5. BioDelivery Sciences Announces Completion of Recruitment in BEMA Buprenorphine Phase 3 Chronic Pain Study
6. ImmuneRegen BioSciences Reports Material Transfer Agreement with VaxGen, Inc.
7. Intellect Neurosciences, Inc. to Present Data on Alzheimers Vaccine at 13th International Congress of Immunology Conference
8. Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents
9. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
10. Upstream Biosciences Acquires Innovative Platform Technology and Drug Candidates for Tropical Parasitic Diseases
11. Human Genome Sciences Completes Enrollment of First Phase 3 Albuferon(R) Trial Ahead of Schedule
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... YORK , April 28, 2016  The blood ... 275 million dollars, according to Kalorama Information and The ... typing, immunoassays and nucleic acid testing.  The healthcare research ... made progress in developing blood collection stations and in ... made in Kalorama Information,s report, Blood Testing ...
(Date:4/28/2016)... , Net Sales of $1.90 billion represent an increase ... period, and an increase of 1.2% on an adjusted pro ... first quarter were $0.52 reported, a decrease of 47.5% from ... 29.9% over the prior year period , The Company ... Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) ...
(Date:4/28/2016)... JERUSALEM , April 28, 2016 ... ), a clinical-stage pharmaceutical company focused on the development of ... participate in the upcoming PIONEERS 2016 conference, presented by ... 5, 2016 in New York . ... overview at the conference. Presentation Details:   ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 29, 2016 , ... Melanoma is the deadliest type of skin cancer. Although ... the majority of skin cancer deaths. More than 10,000 people are expected to die of ... is 62, it is the one of the most commonly diagnosed cancers in young women. ...
(Date:4/29/2016)... ... , ... For those who skip meals occasionally (which is pretty much everyone), ... many new lifestyle diet tips offered by nutritionists Pam Bonney and Priya Lawrence of ... show. Bonny and Lawrence noted that because proper nutrition, including water, provides energy during ...
(Date:4/29/2016)... ... April 29, 2016 , ... CURE Media ... on patients with cancer, today announced that Lynne Malestic, RN, of Eisenhower Lucy ... CURE® Extraordinary Healer® for Oncology Nursing , which honors nurses who have dedicated ...
(Date:4/29/2016)... ... April 29, 2016 , ... International Dehydrated Foods, Inc. (IDF™) will attend and ... at the Doubletree by Hilton Hotel in Oak Brook, Illinois. The two-day event is ... for protein ingredients. , At the seminar, IDF™ will offer samples of its Savory ...
(Date:4/29/2016)... ... April 29, 2016 , ... Intellitec Solutions ... May 16th to 18th at the Broward County Convention Center. The event is ... collaborate on best practices in public facility management. Intellitec Solutions will highlight their ...
Breaking Medicine News(10 mins):